Continued Concerns Over Contamination Risks Involving Medical Devices

Several patients have announced an intention to file product liability lawsuits against the manufacturer of a range of duodenoscopes linked to several cases of deadly hospital infections. Even as these lawsuits proceed, there continues to be questions about what can be done to make these devices easier and safer to use. Worse yet, among these unanswered questions, the scopes remain in use, and as a result, putting other patients at risk.

Several hospitals around the country continue to use the device known as duodenoscopes in spite of a flaw in their design that makes them difficult to sterilize and thus safe for patient use. Duodenoscopes are endoscope-like devices that are used in several medical procedures. The risk associated with these devices only recently made headlines after a major outbreak of the CRE infection in UCLA’s Ronald Reagan Medical Center in Los Angeles. Two patients died as a result of the infection, and several others suffered life-threatening illnesses. Similar outbreaks linked to the devices have also been reported in other facilities around the country, including the cities of Chicago, Pittsburgh, and Seattle. At least two patients died in North Carolina after they developed the CRE infection at a hospital.
The Food and Drug Administration believes the problem is the design of the devices, which makes it more challenging to sterilize. However, hospitals around the country continue to use the duodenoscopes, even in the absence of proper guidelines for sterilization. Neither the government nor the manufacturer of the device has been very forthcoming about providing guidance to use these devices safely. The Food and Drug Administration admits that even when hospitals comply with all manufacturer guidance for proper sterilization procedures, the devices may still be susceptible to contamination.

The Centers for Disease Control and Prevention calls the CRE pathogen a “nightmare bacteria” because of the high rate of fatalities linked to these infections. Approximately 50% of patients who contract CRE infections will die from the infection.

Every year, hundreds of thousands of medical procedures involve the use of the duodenoscopes. The FDA and Olympus, a major manufacturer of the devices, are currently the target of criticism for their failure to warn hospitals about this serious flaw in the device’s design and Olympus is currently facing lawsuits from two patients who contracted the infection.

The medical malpractice lawyers at Montross Miller Muller Mendelson & Kennedy, LLP are dedicated to the representation of persons injured as a result of medical negligence in hospitals across Indiana.